ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
This recall has been completed (originally issued July 13, 2022).
- Company
- Materialise Usa Llc
- Recall Initiated
- July 13, 2022
- Recall Number
- Z-1569-2022
- Quantity
- 1 unit
- Firm Location
- Plymouth, MI
- Official Source
- View on FDA website ↗
Reason for Recall
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
Distribution
US Nationwide distribution in the state of MD.
Lot / Code Info
Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Root Cause
Employee error
Action Taken
Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.